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Clinical safety study on 5-Aminolevulinic acid (5-ALA) in children and adolescents with brain tumors

This study has been transitioned to CTIS with ID 2024-517575-20-00 check the CTIS register for the current data. This study proposes a safety study in children in which tumors are operated on using fluorescence-guided resection which are similar to…

The effects of a colon-delivered multivitamin supplement on vigilance and cognitive performance under stressful working conditions in military subjects

This current study aims to examine the effects of a 6-week colon-delivered multi-vitamin supplement intervention on cognitive performance and stress levels in military under real-life, stressful working conditions.

Optimising recovery after cup revision or liner exchange- is the anterior approach superior to posterolateral?

Does isolated cup revision surgery or liner exchange through the anterior approach result in increased functional status and higher patient satisfaction than through the posterolateral approach?

MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation

Primary objectiveTo evaluate the effects of treatment with MyopiaX on the rate of myopia progression in children and adolescents as reflected in spherical equivalent refraction and axial length changes at 6months relative to baseline.Secondary…

A Phase 2, Open-Label, Adaptive, Dose-Ranging Study with Long-Term Extension to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intra-articular AMB-05X Injections in Subjects with Tenosynovial Giant Cell Tumor

This study has been transitioned to CTIS with ID 2023-507328-22-00 check the CTIS register for the current data. The objectives of this study are to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics of intra-articular (IA)…

A Four-Part, Open Label, Randomized, Parallel Assignment Study to Evaluate the Pharmacodynamics of Nirogacestat on B-Cell Maturation Antigen (BCMA)

Part 1In Part 1 of the study, no study compound will be administered, but a bone marrow aspiration and a blood sample will be taken to evaluate an assay that will be used for Part 2 and Part 3 of the study. Because no nirogacestat is given, we can…

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients with Amyotrophic Lateral Sclerosis (DAZALS)

This study has been transitioned to CTIS with ID 2024-514082-19-00 check the CTIS register for the current data. The aim of this phase 2 study is to investigate the safety and efficacy of dazucorilant in the target ALS patient population.

A single dose, randomised, double-blind 3-arm parallel-group study to compare the pharmacokinetics and α4β7 receptor saturation, for PB016 versus US-licensed and EU-approved Entyvio® after intraveneous administration in healthy subjects

The sponsor is developing a compound (PB016) similar to Entyvio® (vedolizumab, hereafter referred to as Entyvio). As part of medical-scientific studies to confirm the similarity of the biological products, the sponsor wants to compare PB016 with EU-…

A randomized, blinded, placebo-controlled study to assess the safety, tolerability and pharmacokinetics of EGT710 following administration of single and multiple doses to healthy adults.

The purpose of the study is to see if the study compound (EGT710) is safe and tolerated when given to healthy adults. The study will also look at how the body absorbs, breaks down, and gets rid of the study treatment.Approximately 100 healthy…

A placebo-controlled, proof-of-concept study to evaluate the safety and efficacy of Lanifibranor alone and in combination with the sodium-glucose transport protein 2 (SGLT2) inhibitor EmpaGliflozin in patiEnts with Nonalcoholic steatohepatitis (NASH) and type 2 Diabetes mellitus (T2DM)

1. Primary Objective The primary objective of this study is to assess the effect of lanifibranor alone compared toplacebo and the effect of lanifibranor in combination with empagliflozin compared to placeboon HbA1c after a 24-week treatment duration…

A multi-center, randomized, double-blind, parallel-group, 20-week dose-finding study to evaluate efficacy, safety, and tolerability of XXB750 in patients with resistant hypertension

To evaluate the efficacy and dose-response relationship of XXB750 30 mg SC q4w, 60 mg SC q4w, 120 mg SC q4w, and 240 mg SC q4w compared to placebo in reducing the mean 24hr ambulatory systolic blood pressure (mean 24hr SBP) from baseline to Week 12.…

The effect of ingesting a novel fortified plant-based protein mix on acute muscle protein synthesis in older people.

To assess postprandial muscle protein synthesis rates in older males in response to ingesting a blend of plant protein fortified with free leucine as compared to (gold standard) whey protein and compared to a plant protein blend without additional…

Long-term Follow-up Study for Participants Previously Treated with Ciltacabtagene Autoleucel

This study has been transitioned to CTIS with ID 2023-505530-10-00 check the CTIS register for the current data. The purpose of this long-term follow-up study is to monitor the health status of patients who were previously enrolled in cilta-cel…

A phase I, open-label trial to investigate metabolism, pharmacokinetics (following a mass balance design) and absolute bioavailability of BI 690517 (C-14) after oral and intravenous administration in healthy male subjects

The purpose of this study is to investigate how quickly and to which extent the new study compound BI 690517 is absorbed, transported,and eliminated from the body. BI 690517 is an investigational study compound which has not yet been approved for…

A study of the effects of single doses of MK-1167 on neurotransmitter cycling in the brain of healthy adult participants using 13C-Magnetic Resonance Spectroscopy.

To investigate effect of a single dose of MK-1167 on glutamate levels in the brain using MRS. Glutamate is a chemical that sends signals between nerve cells in the brain. To test the safety and tolerability of single oral doses of the trial drug, MK…

Dermal Substitution in Paediatric Burns: A Prospective Case Series

The aim of this study is to investigate the scar quality in a paediatric burn population treated with Glyaderm up to 12 months after surgery.

Towards Precision Medicine for Diabetes in Pregnancy

In the present study, we propose to investigate the efficacy of pharmacological treatment of GDM (using metformin) by the pathophysiological cause of hyperglycemia, namely reduced insulin sensitivity or reduced insulin secretion. Primary Objective:…

Phase 1, open label study of intravenous GSK3745417 to evaluate safety, tolerability, harmacokinetics, pharmacodynamics and determine RP2D and schedule in participants with relapsed or refractory myeloid malignancies including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS)

Primary objective:Part 1: To determine the safety, tolerability, and RP2D of a daily dosing schedule (induction) of GSK3745417 Part 2: To evaluate clinical efficacy following the daily dosing *induction* period of GSK3745417 in participants with…

A randomized, placebo-controlled, double-blind, multi-center Phase 2/3 trial to assess efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with symptomatic polycystic liver disease

This study has been transitioned to CTIS with ID 2023-505313-24-00 check the CTIS register for the current data. To evaluate the treatment effect of CAM2029 compared to placebo on liver volume in patients with polycystic liver disease (PLD)

A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors

This study has been transitioned to CTIS with ID 2023-506604-18-00 check the CTIS register for the current data. Primary:- To evaluate the safety and tolerability of SGN-PDL1V in subjects with advanced solid tumors.- To identify the maximum…